Regulatory Overview: The Regulations Applied to Social and Behavioral Sciences Content Author: Lorna Hicks Duke University This module has 7 parts and will require about 20 minutes to complete. Take the short quiz at the end of the module before proceeding to the next module. Introduction Researchers in the social and behavioral sciences and the humanities often assert that the regulations for the protection of human research subjects don't really apply to the kind of research that they do, believing that the rules were written exclusively for biomedical research. There is a kernel of truth in this because revelations in the early 1970s about egregious medical experiments provided the impetus for developing federal standards for protecting human research. However, a close reading of the regulations will find mention of research methods and topics of inquiry relevant for researchers in the social and behavioral sciences and the humanities. Methods include surveys, interviews, focus groups, oral history, participant observation, observations of public behavior, and the analysis of existing data. Topics include research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior.
Transcript
Regulatory Overview: The Regulations Applied to Social and Behavioral SciencesContent Author:
Lorna HicksDuke University
This module has 7 parts and will require about 20 minutes to complete. Take the short quiz at the end of the module before proceeding to the next module.
Introduction
Researchers in the social and behavioral sciences and the humanities often assert that the regulations for the protection of human research subjects don't really apply to the kind of research that they do, believing that the rules were written exclusively for biomedical research. There is a kernel of truth in this because revelations in the early 1970s about egregious medical experiments provided the impetus for developing federal standards for protecting human research.
However, a close reading of the regulations will find mention of research methods and topics of inquiry relevant for researchers in the social and behavioral sciences and the humanities. Methods include surveys, interviews, focus groups, oral history, participant observation, observations of public behavior, and the analysis of existing data. Topics include research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior.
In addition to explicitly identifying these methods, the regulations include provisions that allow for appropriate review of social science, humanities, and behavioral research. For example, the regulations:
Identify research activities that are low risk, for example, a survey in which no identifiers are collected, and that are thus exempt from the remaining provisions of the regulations, such as the requirement for continuing review.
Identify research activities with no more than minimal risk that can be reviewed by one or more Institutional Review Board (IRB) members, rather than at a convened IRB meeting.
Allow for waivers of the requirement to obtain written consent, for example, in a study of undocumented workers.
Include provisions that permit researchers to withhold information in the consent process. This provision is important when some degree of deception is required in order to obtain valid results.
Allow for the amendment of approved protocols. This process can be used effectively when it is not possible to know at the outset how a study will evolve, for example when the study employs community-based participatory research methods.
Require that IRBs have the necessary competence to review specific research activities.
This module will provide an overview of the federal regulations so that researchers can become conversant with their basic provisions. The full text of the regulations is available on line. For a complete discussion about the flexibility in the regulations regarding the consent process, see the module Informed Consent.
Module Contents
1. Title 45 CFR 462. Contents of the Federal Regulations3. What must be reviewed?4. Expedited or full review?5. Who must review research with human subjects?6. What questions must be addressed during a review?7. Reviews throughout the life of a project8. Other issues
1.0 Title 45 Code of Federal Regulations Part 46: Protection of Human Subjects
The Department of Health and Human Services (DHHS) regulations are sometimes referred to as 45 CFR 46, a label that identifies their location in the Code of Federal Regulations. You will probably see 45 CFR 46 quoted in your institution's policies and resource materials.
Subpart A of 45 CFR 46 is often referred to as the "Common Rule." Although these regulations were first drafted and adopted by DHHS, most departments that fund research in the social and behavioral sciences, including the National Science Foundation and the Department of Education, subsequently adopted the regulations, thus the designation "Common Rule."
Additional Protections for Vulnerable Subjects
Three subparts have been added to the basic provisions, Subpart A, of the federal regulations:
1. Subpart B: Pregnant women, fetuses, and neonates2. Subpart C: Prisoners3. Subpart D: Children
Note: The additional protections for prisoners and children are covered in Modules 7 and 8, respectively, and will not be discussed here. The additional protections for pregnant women, fetuses, and neonates are most relevant in biomedical research.
It should be noted that some federal agencies that adopted the Common Rule have also adopted some or all of the other subparts of the DHHS regulations, but others have not. For example, while the Department of Education has adopted the additional protections for children, the National Science Foundation has not.
Assurances with the Office of Human Research Protections
Every institution conducting research with federal support is required to enter into an agreement called an "assurance."� Most assurances are negotiated with the DHHS Office of Human Research Protections (OHRP).� An assurance identifies the regulations for protecting research subjects that the institution will follow and the ethical principles it will adopt. In the United States these are the Common Rule and the Belmont Report. �The assurance also states how broadly the institution will apply the Common Rule and the additional subparts. Some institutions apply the Rule to all research regardless of the source of funding. This means that the Rule would apply to research funded by foundations, associations, internal award programs, all other sources of research support, and when research is not funded. Some institutions also choose to apply the additional subparts, B, C, and D, to all research regardless of the source of funding. Others choose to apply the subparts only to federally funded research.
2.0 Content of the Federal Regulations
The federal regulations for protecting research subjects describe:
What research must be reviewed,
Who must review it, What questions should be
addressed during a review, and What kinds of review need to take place during the life of a project.
It is important to note that the federal regulations are intended to provide minimum standards and may be supplemented by institutional policy.
3.0 What Must Be Reviewed
The first step in deciding whether a project needs review is to determine whether it meets the definition of research with human subjects. If it doesn't meet the definition, it doesn't require review by an IRB, although there may be ethical issues that must be addressed by the
See the module Defining Research with Human Subjects for a discussion about how to apply the following definitions:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
1. Data through intervention or interaction with the individual, or2. Identifiable private information.
Once it has been determined that a project meets the definition of research with human subjects, the next step is to determine the type of review it needs. The type of review determines who will conduct the review.
Research Eligible for Exemption
Of significant interest to social and behavioral scientists is the fact that there are activities that do meet the definition of research with human subjects but are not covered by the provisions of the Common Rule. Thus they do not require review as described in the Rule.
While these studies do not require review in accordance with the Rule, some procedure is necessary to make the determination that they are eligible for exemption. Institutional procedures vary, but the common element is that the institution, not the investigator must make the determination.
Research may be eligible for exemption from the Common Rule if all the activities associated with the research fall into one or more of six categories. Of the six categories, three are frequently used by social and behavioral scientists. They are:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices.
2. Research involving survey procedures, interview procedures, or observation of public behavior providing that any disclosure of identifiable information outside the research setting would not place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
NOTE: If Subpart D applies, either by sponsor requirement or institutional choice, the following activities with children cannot be exempt: interviews, surveys, and participant observation.
3. Research involving the collection or study of existing data (collected prior to the
research for purposes other than the research) if the data are publicly available or recorded by the investigator in such a manner that the subjects cannot be identified.
A complete list of research activities eligible for exemption is provided at 45 CFR 46.101.
4.0 Expedited or Full Review
If research is not eligible for exemption, the remaining options are expedited or full review.
To be eligible for expedited review research must meet two criteria:
1. Pose no more than minimal risk to subjects.
"No more than minimal risk" means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
2. Consist only of one or more research activities specified in the regulations as eligible for expedited review.
Eligible activities are similar to those for exempt research (some surveys, interviews, and data analysis) with the addition of some minor or non-invasive medical procedures, such as blood pressure readings, weight measurements, and blood draws that are used occasionally by researchers in the social and behavioral sciences.
The preamble to the list of specified activities notes that if the primary risk to subjects is a breach of confidentiality and the risk can be managed to no more than minimal, then the research may be reviewed through an expedited process.
Institutional policy, local conditions, and subject vulnerability may require review by a convened Institutional Review Board (IRB) even for a study with no more than minimal risk, such as a study of decisionally-impaired individuals. If research involves more than minimal risk and/or does not fall into one of the categories of research eligible for expedited review, it must be reviewed by a convened IRB. This review involves consideration by a larger, more diverse group, thus bringing more perspectives and more experience to the review.
As prescribed in the regulations and implemented by institutional policy there are three possible sets of reviewers:
1. Staff or IRB members identified by the institution to screen research for exempt status. 2. One or more IRB members conducting expedited reviews.3. Members of a convened IRB for studies requiring full review.
Description of an Institutional Review Board
An Institutional Review Board is a review committee established to ensure that the rights and welfare of human research subjects are protected. Although federal regulations use the term IRB, institutions may choose a different name for the committee, such as Research Ethics Board.
Membership
The minimum size and required composition of an IRB is spelled out in detail in the regulations. An IRB must have at least five members. Its membership must be diverse including considerations of race, gender, and cultural background. The committee is expected to be sensitive to community attitudes; have knowledge and experience with vulnerable populations; and to be conversant with applicable regulations, state and local laws, and standards of professional conduct.
The most important requirement is that an IRB must have the expertise and professional competence to evaluate research. One or more members must have familiarity with the discipline and methods under consideration. If not, the IRB must seek that expertise through consultation. For example, if an IRB is to review research on sensitive topics using web-based surveys, it must have expertise about security issues in the Internet environment or seek outside consultation.
Authority of the Institutional Review Board
Federal regulations stipulate that an IRB can:
Approve research. Disapprove research. Require modifications to proposed
research. Conduct continuing reviews. Observe/verify changes. Suspend or terminate approval.
Observe the consent process and the research procedures.
The regulations also require that IRBs develop procedures for handling noncompliance.Other Institutional Reviews
Research approved by an IRB may be subject to further review and approval or disapproval by officials of the institution (for example, department heads, deans, research directors). However, if an IRB has disapproved the research, the institution cannot override that determination.
6.0 What Questions Must Be Addressed During a Review
Exempt Research
When research is exempt from the provisions of the Common Rule, it follows that the review criteria provided for expedited and full review would not apply. However, all research should abide by the three basic ethical principles elucidated in the Belmont Report: respect for persons, beneficence, and justice. Thus, for example, the principle of respect for persons would entail securing informed consent from research subjects. Therefore, many institutions have developed forms designed to gather sufficient information to determine not only that a project is exempt, but that it is being conducted in accordance with basic ethical principles.
Review Criteria for Expedited and Full Review
IRB members who are conducting an expedited review, or the convened IRB conducting a full review, must ask the following questions:
1. Have the risks to subjects been minimized using procedures that are consistent with sound research design?
2. Are the risks reasonable in relation to anticipated benefits?
3. Is the selection of subjects equitable? 4. Are adequate procedures in place to ensure privacy and
confidentiality? 5. Is there a plan to monitor the data and safety of the
subjects, if necessary? 6. Will informed consent be sought and appropriately
documented? Do proposed alterations or waivers of informed consent meet the criteria for approval?
7. Are safeguards in place to protect vulnerable populations?
Review procedures for expedited review and full review are similar in several ways:
The review criteria are the same. Both types of review are documented communication processes between
investigators and reviewers. Expediting reviewers and the full IRB can request modifications to submissions
and can approve protocols, continuing reviews, and amendments to approved protocols.
Expediting reviewers and the IRB will specify when a protocol must be reviewed again. By regulation it must be within twelve months, but shorter review periods may be required.
A key difference between the two processes is that expedited reviewers cannot disapprove a protocol. They must refer protocols they cannot approve to the full IRB. All IRB members must be advised about protocols, continuing reviews, and amendments approved through expedited review procedures. Any member of the IRB may request that such approvals be reconsidered by the full IRB.
7.0 Reviews throughout the Life of a Project
Once a protocol has received initial approval through expedited or full review procedures, it must be reviewed, according to procedures described in the Common Rule, within twelve months of its approval date. In addition, changes to approved protocols must be approved prior to implementation, and reports of unanticipated problems must be reviewed.
Continuing Review: Expedited or Full?
Federal regulations permit expedited review to be used for continuing review if the initial review was expedited and no new risks were identified. It may also be used when the initial review was conducted by a full IRB under some circumstances, such as 1) when no additional risks have been identified and during the initial review the IRB determined and documented that the research involves no greater than minimal risk, or 2) the remaining activities are limited to data analysis.
The IRB or the expediting reviewer(s) must determine that all the requirements for initial review continue to be satisfied.The Common Rule also requires that continuing review cover specific information, including the
number of subjects accrued, a summary of any relevant recent literature, a description of any unanticipated problems, and a copy of the current consent form.Follow the link to the view the latest Guidance from the OHRP on Continuing Review.
Amending Approved Protocols
Changes to approved protocols must be approved prior to their implementation. The regulations state that expedited review procedures may be used to approve "minor changes in previously approved research during the period (of one year or less) for which approval is authorized." Consult with your IRB about your institution's policies and procedures regarding these reviews and about what constitutes a "minor" change.
Proposed changes to exempt research must be reviewed in some manner to ensure that the revised research still meets the criteria for exemption.
Reports of Unanticipated Risks or Harms
Institutions conducting research under the auspices of an assurance with OHRP are required to develop written procedures for reporting and reviewing unanticipated problems involving risks or harms to research subjects.
8.0 Other Issues
The regulations cover other issues not addressed in this module such as working with collaborators, both domestic and international, required record keeping, and suspension and termination of IRB approved research.
